Danish Multicenter Study of Adalimumab in Spondyloarthritis

Sponsor
Glostrup University Hospital, Copenhagen
Study ID
NCT00477893
Phase
PHASE4
Status
Unknown

Conditions

  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
  • Placebo — DRUG
    sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.

Study Details

Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

Key Dates

Start date
Feb 28, 2006
Status verified
Mar 2012
Primary completion
Jan 31, 2009
Completion
Jan 31, 2013

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Adalimumab

Primary Outcome Measure

Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ]

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